Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers

Pharmacokinetics Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215941
• Other study ID #: TV45070-PK-10033
• Status: Completed
• Phase: Phase 1
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects aged 18 to 50 years

• Body Mass Index (BMI) =18.0 and =32.0 kg/m2.

• Able and willing to provide written informed consent.

• Able and willing to comply with all study procedures and restrictions.

Exclusion Criteria:

• History or evidence of clinically significant illness or surgery

• Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies.

• History of significant drug or alcohol abuse

• Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.

• Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1.

• Pregnant or nursing females

• Shaving or waxing the planned study treatment application area within 7 days prior Day 1.

• Laser hair removal of the planned study treatment application area within 2 months prior to Day 1.

• other criteria apply, please contact the investigator for more information

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• TV-45070
TV-45070 8% ointment
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Teva Investigational Site 12961	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations		Day 8
Secondary	Drug level in skin		Days 1, 8, 15, 22, 29
Secondary	Excretion of drug in urine		Day 8
Secondary	Identification of metabolites in blood		Days 8, 10
Secondary	Identification of metabolites in urine		Day 8
Secondary	Identification of metabolites in skin		Days 1, 8, 15, 22, 29
Secondary	Intraepidermal nerve fiber density in skin		Days 1, 8, 15, 29
Secondary	Percentage of Participants with Adverse Events		10 Weeks